Director, Clinical Scientist

Aktis Oncology, Inc. is a clinical-stage oncology company focused on expanding the breakthrough potential of targeted radiopharmaceuticals to large patient populations, including those not addressed by existing platform technologies. Aktis’ most-advanced program, AKY-1189, is a miniprotein radioconjugate targeting Nectin-4, with multi-indication potential across multiple tumor types, including locally advanced or metastatic urothelial cancer, breast cancer, non-small cell lung cancer, colorectal cancer, cervical cancer, and head and neck cancer. Aktis’ second pipeline program, AKY-2519, is a miniprotein radioconjugate targeting B7-H3 expressing tumors, including prostate, lung, and other solid tumors. Aktis has a strategic collaboration with Eli Lilly and Company to leverage its miniprotein platform to develop novel radioconjugates outside of Aktis’ proprietary pipeline.

Aktis Oncology is seeking a Clinical Scientist with extensive oncology expertise to work across all aspects of clinical development with a focus on early-phase activities.  

Responsibilities

• Clinical Synopsis, Protocol, and ICF development process, including template creation, authoring, reviewing, adjudication, and resolution of cross-functional comments, in collaboration with Medical Writer.
• Serve as drug product, protocol, and project subject-matter expert for all stakeholders.
• Support and guide the development of the data review strategy, ensuring that protocol-level deviations, eligibility criteria, study assessments & other aspects of the protocol are implemented consistently across the study (across countries/ sites). This could also include support for Case Report Form (CRF) development and implementation of data capture tools.
• Work to improve the quality of reviews/ insights with an emphasis on subject safety and eligibility, data integrity, trend identification, analysis and remediation, and identification of cases for medical review.
• Provide guidance on clinical protocol, procedures, and the development of eCRF design and study plans.
• Support pharmacovigilance activities (e.g., contributing to aggregate reports, patient narratives, attendance of pharmacovigilance monitoring meetings).
• Clinical Site facing activities: Assist in the development of site and CRA training materials and present at SIVs and Investigator meetings.
• Deliver quality study strategy and design, including analysis and interpretation of data throughout the study, including leading clinical data review with Data Management; develop and review clinical narratives; and monitor clinical data for specific trends.
• Liaise with clinical monitors to understand any trends in data management issues and work to develop solutions.
• Review/query clinical trial data – monitor data quality for trends, and ensure appropriate quality measures are in place; provide trends and escalate questions to the Medical Monitor.
• Ensure consistency of study execution to facilitate data analysis and regulatory filing.
• Support study-specific vendor interaction and coordination.
• Contribute to clinical study and program timelines, review study feasibility, perform risk assessments, and identify and execute mitigation and contingency planning efforts with Program Management and Clinical Operations functions.
• Maintain understanding of therapy competitors and clinical developments in relevant therapeutic areas by attending scientific meetings, maintaining relationships with KOLs, and tracking literature.
• Support execution of Safety Review Committee/Data Safety Review Board and clinical advisory board meetings, including scheduling, agenda and presentation development, and socializing of pre-reads to all attendees.
• Serve as a clinical science lead on study team meetings and contribute to program-level activities.
• Review and enhance the technical and scientific robustness of program-level clinical development plans.
• Contribute to the development of end-to-end clinical development strategy.
• Contribute to the development of Statistical Analysis Plans, IND, Investigators’ Brochure, IRB responses, CSRs, and other study-related documents. Author relevant sections of clinical and regulatory documents.
• Ensure compliance with ICH/GCP guidelines, all applicable laws and regulations, and SOPs for all products and services delivered for designated studies.
• Support regulatory interactions, including through briefing documents, presentations, questions, and responses.

Qualifications

• Advanced degree in Life Sciences with 10 years of experience. 
• Prior radiopharmaceutical experience a plus. Solid tumor study experience required.
• 6 years as a Clinical Scientist or comparable role in Clinical Development, with a minimum of 2 years Sponsor experience.
• Working knowledge of GCP/ICH, drug development process, study design, statistics, and clinical operations.
• GCP/ICH experience, including writing and/or reviewing study protocols, procedures manuals, ICFs, and clinical study reports.
• Ability to understand assigned clinical protocol(s), their requirements, and support program-specific data review and trend identification.
• Strong project management capabilities with demonstrated ability to problem-solve and mediate complex issues
• Outstanding written and oral communication skills for clinical, business, and scientific audiences.
• Strong sense of urgency and excellence in prioritization, planning, and execution
• Strong interpersonal skills and ability to thrive in a matrix environment.
• Highly adept at solving complex, cross-functional problems.
• Effective verbal and written communication skills within and outside the company
• Flexibility to work on multiple projects as the portfolio evolves over time.
• Meticulous attention to detail, including the capacity to conduct thorough self-reviews.
• Highly organized, collaborative, and motivated in a fast-paced startup environment.
• Strong desire to be part of a mission-oriented company leading transformative changes for patients.
• Proven demonstration of transparent communication and fostering open and diverse debate.
• Ability to work with agility and manage ambiguity.
• Personifies positive energy and exemplifies respect.

Aktis Oncology is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity or expression, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. Aktis Oncology is committed to promoting and maintaining a work environment in which all applicants, employees, and other individuals are treated with dignity and respect free from unlawful harassment, discrimination, or retaliation.